Inspections, Compliance, Enforcement, and Criminal Investigations
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2010 Warning Letters
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Warning Letters issued in 2010
* Not issued: A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.
* N/A: Not applicable, the Warning Letter was issued prior to September 1, 2009.
Read more about warning and close-out letters
Posted on April 19, 2010
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| April 08, 2010 | Bryant Ranch Prepack Inc. | Los Angeles District Office | New Drug/Labeling/Misbranded/Adulterated | Not Issued * |
| April 08, 2010 | The Children's Hospital Assoc. Transfusion Medicine Services | Denver District Office | CGMP for Blood & Blood Products/Adulterated | August 08, 2011 |
| April 07, 2010 | Wake Forest University Baptist Medical Center | Atlanta District Office | Device/Adulterated | Not Issued * |
| April 06, 2010 | Pure Med Spa | Center for Drug Evaluation and Research | Lipodissolve/False & Misleading Claims/Misbranded | Not Issued * |
| April 06, 2010 | Aloha Medicinals Inc. | San Francisco District Office | New Animal Drug/Labeling/Misbranded/Adulterated | Not Issued * |
| April 05, 2010 | Innovative Directions in Health | Center for Drug Evaluation and Research | Lipdissolve/False & Misleading Claims/Misbranded | February 10, 2011 |
| April 05, 2010 | Spa 35 | Center for Drug Evaluation and Research | Lipodissolve/False & Misleading Claims/Misbranded | May 21, 2010 |
| April 05, 2010 | Monarch Med Spa | Center for Drug Evaluation and Research | Lipodissolve/False & Misleading Claims/Misbranded | May 21, 2010 |
| April 05, 2010 | All About You Medspa, LLC | Center for Drug Evaluation and Research | Lipodissolve/False & Misleading Claims/Misbranded | May 21, 2010 |
| April 05, 2010 | Medical Cosmetic Enhancements | Center for Drug Evaluation and Research | Lipodissolve/False & Misleading Claims/Misbranded | May 21, 2010 |
| April 05, 2010 | 7Seas LLC | Florida District Office | Dietary Supplement Regulations/Misbranded | Not Issued * |
| April 05, 2010 | All About You Medspa, LLC | Center for Drug Evaluation and Research | Lipodissolve/False & Misleading Claims/Misbranded | Not Issued * |
| April 02, 2010 | Wright Place, LLC | New England District Office | Illegal Drug Residue | Not Issued * |
| April 01, 2010 | Yurkanin, John B | Philadelphia District Office | Illegal Drug Residue | Not Issued * |
| April 01, 2010 | Deitz, Robert, M.D. | Center for Drug Evaluation and Research | Clinical Investigator | Not Issued * |
| March 31, 2010 | Cut Fruit Express, Inc. | Minneapolis District Office | CGMP for Foods/HACCP/Adulterated | February 08, 2011 |
| March 30, 2010 | Coats International Holdings, Inc | Dallas District Office | CGMP Manufacture, Processing, Packing or Holding/Adulterated | Not Issued * |
| March 30, 2010 | Wisconsin Brother's Bakery, Inc | Minneapolis District Office | Labeling/False & Misleading Claims/Misbranded | Not Issued * |
| March 29, 2010 | IVF Phoenix | Los Angeles District Office | Human Cells, Tissues & Cellular Products | July 18, 2011 |
| March 29, 2010 | Apotex Inc. | Center for Drug Evaluation and Research | CGMP for Finished Pharmaceuticals/Adulterated | July 01, 2011 |
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